When a patient is a candidate for stimulation therapy such as sacral nerve stimulation or spinal cord stimulation therapy to treat incontinence, chronic pain, or related conditions, it is often desirable to conduct a trial period of stimulation. This trial period allows an external stimulator to be used so that the patient is not required to undergo a full stimulation device implantation procedure. If the trial is successful, then an implantable stimulator is fully implanted into the patient.
When implanting the trial system, an implantable medical lead is implanted with a distal end being routed to the stimulation site. An implantable lead extension is typically then routed subcutaneously from the location of the proximal end of the implanted medical lead to an exit site nearby the location where the external device will be mounted to the patient. An external lead is then used to interconnect the exposed proximal end of the implantable lead extension to the external device.
One issue with the external lead is that it requires a step of connecting the external device and to the lead extension. While this allows the lead extension to be shorter, and thus less burdensome during implantation and during the trial period, the external lead itself introduces the burden of having to install it and then have it be present during trialing. Thus, the external lead has two external connections, and both must be maintained during the trial period.
In addition to the burdens of the external lead, the implantation procedure has additional burdens related to accessing the tools needed to complete the implantation procedure. A nurse within a non-sterile field provides the packaging of the tools. A sterile nurse must then access the tools from the packaging and place the tools on a surgical tray within the sterile field. Meanwhile, the packaging is discarded. These steps add to the time and inefficiencies of the implantation procedure.